NCT04468594

Brief Summary

the current study tends to compare the effect of two different treatment techniques used in the rehabilitation of shoulder impingement syndrome. rigid tapping and scapular stabilizing exercises will be applied and the level of function and pain intensity will be measured before and after the intervention and at 3 months follow up. while both methods of treatment used previously, the comparison between their effects is not yet investigated and no data is available regarding the superiority of one over the other.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

May 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

July 3, 2020

Last Update Submit

November 8, 2022

Conditions

Keywords

Impingement Syndrome- rigid tape-scapular stabilizing

Outcome Measures

Primary Outcomes (1)

  • The Shoulder Pain and Disability Index (SPADI)

    The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.

    Change from Baseline Shoulder pain and function at 3 months"

Secondary Outcomes (1)

  • pain (visual analouge scale)

    Change from Baseline Shoulder pain at 3 months"

Study Arms (3)

rigid tape

EXPERIMENTAL

the rigid tapping technique using zinc oxide tape and protective tape (reference). With the participant assuming a relaxed standing position, the tape was applied bilaterally starting from the first to the last thoracic vertebra. A second tape was then applied to form a position of scapular depression and retraction. This tape was applied bilaterally and extended from the midpoint of the spine of the scapula to the last thoracic vertebra (figure ). This taping was applied for 12 weeks and changes every 3 days

Other: rigid tappingOther: therapeutic exercises

scapular stabilizing exercises

EXPERIMENTAL

scapular stabilizing exercises in the form of (1)wall slides with squat, (2) Wall push-ups with ipsilateral leg extension, (3) lawnmower with diagonal squat, (4) resisted retraction to scapula with opposite leg squat (5) robbery with squat. ten repetitions / exercises/ session were perform

Other: scapular stabilizing excerciseOther: therapeutic exercises

control

ACTIVE COMPARATOR

a standard physical therapy protocol will be introduced. This protocol consisted of (1) progressive strengthening exercises for rotator cuff muscles. The resistance was applied first by a red-colored elastic Thera-band. Then progressed, using the green-colored band. Each exercise was performed 10 times /session, (2) Self-stretching exercises for levator scapula, posterior deltoid, pectoralis minor, and latissimus dorsi muscles. Five repetitions of stretching were performed for each muscle per session

Other: therapeutic exercises

Interventions

Taping techniques We will use rigid tape and apply it bilaterally. In the rigid tape application, a combination pack of zinc oxide tape and the protective tape will be used. The protective tape will be applied first with no tension. To apply the rigid tape, subjects will be instructed to place their thoracic spine in a neutral position, the rigid tape will be applied bilaterally from the first to the twelfth thoracic vertebra. Subjects will be asked to retract and depress the scapula. The rigid tape will be applied diagonally from the middle of the scapular spine to the twelfth thoracic vertebra; this technique will be applied bilaterally. The rigid tape will be applied 3 times per week and will be applied for 6 weeks.

rigid tape

consisted of: 1. wall slides with squat, 2. wall push-ups plus ipsilateral leg extension, 3. lawnmower with diagonal squat, 4. resisted scapular retraction with contralateral leg squat and robbery with squat. 5. Robbery with squat 6. Resisted shoulder internal rotation with step 7. Resisted shoulder external rotation with step 8. Resisted full can with step All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands The patient will perform 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly.

scapular stabilizing exercises

1. Pectoralis minor stretching 2. Posterior shoulder stretching 3. Levator scapula stretching 4. Latissimus dorsi stretching ( stretching exercises will be 5 repetitions each session - 3 times per week) 5. Resisted shoulder internal rotation 6. Resisted shoulder external rotation 7. Resisted full can (strengthening exercises will be 510 repetitions each session - 3 times per week) All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands NOTE. All resisted exercises were progressed from starting 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly, supervising movement quality, presence of pain, and fatigue. If the subject achieves 20 repetitions 3 successfully, heavier resistance with resistance band color-coded loading prescribed from 10 repetitions 3 sets.

controlrigid tapescapular stabilizing exercises

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects having positive results to at least 4 of the following tests:
  • Neer impingement sign
  • Hawkins sign
  • pain during supraspinatus empty can test
  • the painful arc between 60⁰\_ and 120⁰
  • tenderness when palpating the greater tuberosity of the humerus -

You may not qualify if:

  • Subjects will be excluded if they have;
  • cervical spine involvement;
  • the presence of a glenohumeral joint adhesive capsulitis, or instability;
  • a history of previous shoulder surgery;
  • upper-limb fracture;
  • had systemic illnesses,
  • receiving another physiotherapy treatment of this disorder in the past 6 weeks; or
  • receiving steroid injection into or around the shoulder in the past 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hail

Ha'il, Ha'il Region, 81451, Saudi Arabia

Location

Related Publications (17)

  • Buttagat V, Taepa N, Suwannived N, Rattanachan N. Effects of scapular stabilization exercise on pain related parameters in patients with scapulocostal syndrome: A randomized controlled trial. J Bodyw Mov Ther. 2016 Jan;20(1):115-122. doi: 10.1016/j.jbmt.2015.07.036. Epub 2015 Jul 26.

    PMID: 26891646BACKGROUND
  • Cools AM, Witvrouw EE, Danneels LA, Cambier DC. Does taping influence electromyographic muscle activity in the scapular rotators in healthy shoulders? Man Ther. 2002 Aug;7(3):154-62. doi: 10.1054/math.2002.0464.

    PMID: 12372312BACKGROUND
  • De Mey K, Danneels L, Cagnie B, Van den Bosch L, Flier J, Cools AM. Kinetic chain influences on upper and lower trapezius muscle activation during eight variations of a scapular retraction exercise in overhead athletes. J Sci Med Sport. 2013 Jan;16(1):65-70. doi: 10.1016/j.jsams.2012.04.008. Epub 2012 May 31.

    PMID: 22658589BACKGROUND
  • Green S, Buchbinder R, Glazier R, Forbes A. Systematic review of randomised controlled trials of interventions for painful shoulder: selection criteria, outcome assessment, and efficacy. BMJ. 1998 Jan 31;316(7128):354-60. doi: 10.1136/bmj.316.7128.354.

    PMID: 9487172BACKGROUND
  • Hebert LJ, Moffet H, McFadyen BJ, Dionne CE. Scapular behavior in shoulder impingement syndrome. Arch Phys Med Rehabil. 2002 Jan;83(1):60-9. doi: 10.1053/apmr.2002.27471.

    PMID: 11782834BACKGROUND
  • Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.

    PMID: 12804509BACKGROUND
  • Kalter J, Apeldoorn AT, Ostelo RW, Henschke N, Knol DL, van Tulder MW. Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial. BMC Musculoskelet Disord. 2011 Aug 17;12:188. doi: 10.1186/1471-2474-12-188.

    PMID: 21849055BACKGROUND
  • Kamkar A, Irrgang JJ, Whitney SL. Nonoperative management of secondary shoulder impingement syndrome. J Orthop Sports Phys Ther. 1993 May;17(5):212-24. doi: 10.2519/jospt.1993.17.5.212.

    PMID: 8343779BACKGROUND
  • Kaya E, Zinnuroglu M, Tugcu I. Kinesio taping compared to physical therapy modalities for the treatment of shoulder impingement syndrome. Clin Rheumatol. 2011 Feb;30(2):201-7. doi: 10.1007/s10067-010-1475-6. Epub 2010 Apr 30.

    PMID: 20443039BACKGROUND
  • Kibler WB, McMullen J, Uhl T. Shoulder rehabilitation strategies, guidelines, and practice. Orthop Clin North Am. 2001 Jul;32(3):527-38. doi: 10.1016/s0030-5898(05)70222-4.

    PMID: 11888148BACKGROUND
  • Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. doi: 10.1016/j.jse.2008.06.004. Epub 2008 Oct 2.

    PMID: 18835532BACKGROUND
  • Lewis JS, Wright C, Green A. Subacromial impingement syndrome: the effect of changing posture on shoulder range of movement. J Orthop Sports Phys Ther. 2005 Feb;35(2):72-87. doi: 10.2519/jospt.2005.35.2.72.

    PMID: 15773565BACKGROUND
  • Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Phys Ther. 2000 Mar;80(3):276-91.

    PMID: 10696154BACKGROUND
  • Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther. 2009 Feb;39(2):90-104. doi: 10.2519/jospt.2009.2808.

    PMID: 19194022BACKGROUND
  • McClure P, Greenberg E, Kareha S. Evaluation and management of scapular dysfunction. Sports Med Arthrosc Rev. 2012 Mar;20(1):39-48. doi: 10.1097/JSA.0b013e31824716a8.

    PMID: 22311292BACKGROUND
  • McClure PW, Bialker J, Neff N, Williams G, Karduna A. Shoulder function and 3-dimensional kinematics in people with shoulder impingement syndrome before and after a 6-week exercise program. Phys Ther. 2004 Sep;84(9):832-48.

    PMID: 15330696BACKGROUND
  • Miller P, Osmotherly P. Does scapula taping facilitate recovery for shoulder impingement symptoms? A pilot randomized controlled trial. J Man Manip Ther. 2009;17(1):E6-E13. doi: 10.1179/jmt.2009.17.1.6E.

    PMID: 20046559BACKGROUND

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ibrahim M dewir, Assist .prof

    physical therapy dep, College of Applied Medical Sciences, Taif University, S.A

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
the process of allocation will be concealed using non transparent envelops that contain a code number. these codes indicated one of the three groups. the interpretation of these codes will be with an author who will not be involved in assessment or treatment procedures. At the day of the first intervention session, the code interpretation will be available
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 13, 2020

Study Start

May 30, 2021

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

this is the policy of the laboratory where the practical part will be conducted

Locations